The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Are you looking to leverage your experience to be part of something big and help people take control of their health? Do you enjoy building and managing relationships to better understand the needs of the business, and then creating and implementing solutions to meet those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, then we have an opening for you!
Our Quality Assurance team are looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As aQuality Assurance Manager, you will manage the development and implementation of the organization’s quality policies and programs. You will also be responsible for ensuring systems comply with FDA and ISO quality system regulations.
Where you come in:
1. The Quality Assurance Manager provides support for the projects, functions, and strategic objectives of the Incoming Inspection, Lot Release, Compliance and document control and training areas.
2. You are a strong tactical decision-maker, handles unforeseen issues as they relate to Dexcom’s compliance with regulations and each supplier’s conformance to required regulations.
3. You regularly interact with senior management or executive levels on matters regarding Dexcom’s compliance with regulations and each supplier’s conformance to required regulations.
4. You exercise supervision in terms of costs, methods, and staffing.
5. You design and maintain the quality system according to written policies and procedures.
6. You understand domestic and international Quality System Requirements and how they interact to be able to provide quality guidance to other departments and companies. Must have the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
7. You establish operational objectives and work plans for the Quality Department and delegates assignments. Specifically, assuring your team are meeting sustaining and research and development project deliverables, creating communication between cross-functional departments, participating in process or product investigations, identifying potential root causes and providing business solutions.
8. You utilize quality feedback data from customers, consumers and internal inputs to drive continual improvement activities needed to achieve department strategic goals.
9. Lead the team that manages projects and non-conformance as it relates to the product and processes.
What makes you successful:
10. You review data on product defects, product response plans and product dispositions; recommends and implements improvements.
11. You have knowledge of techniques like six sigma, lean manufacturing, sampling plans and other statistical modelling.
12. You take the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
What you’ll get: (this section should not be modified)
13. A front row seat to life changing CGM technology. .
14. A full and comprehensive benefits program.
15. Growth opportunities on a global scale.
16. Access tocareer development through in-house learning programs and/or qualified tuition reimbursement.
17. Anexciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
18. 10-15%